• Xavier Pivot, Alexey Manikhas, Bogdan Żurawski, Ewa Chmielowska, Boguslawa Karaszewska, Rozenn Allerton, Stephen Chan, Alessandra Fabi, Paolo Bidoli, Stefania Gori, Eva Ciruelos, Magdolna Dank, Lajos Hornyak, Sara Margolin, Arnd Nusch, Roma Parikh, Fareha Nagi, Michelle DeSilvio, Sergio Santillana, Ramona F Swaby, and Vladimir Semiglazov.
• Xavier Pivot, Centre Hospitalier Universitaire, Hôpital Jean Minjoz, Besançon, France; Alexey Manikhas, St Petersburg City Oncology Dispensary; Vladimir Semiglazov, Petrov Research Institute of Oncology, St Petersburg, Russian Federation; Bogdan Żurawski, Franciszek Lukaszczyk Oncology Center, Bydgoszcz; Ewa Chmielowska, Centrum Onkologii im. Prof Franciszka Lukaszczyka Oddzial Kliniczny Onkologii, Bydgoszcz, and Uniwersytet Mikolaja Kopernika Torun, Torun; Boguslawa Karaszewska, Przychodnia Lekarska KOMED, ul Wojska Polskiego 6, Konin, Poland; Rozenn Allerton, The Royal Wolverhampton Hospitals National Health Service Trust, Wolverhampton; Stephen Chan, Nottingham University Hospital, Nottingham; Roma Parikh and Fareha Nagi, GlaxoSmithKline, Uxbridge, United Kingdom; Alessandra Fabi, "Regina Elena" National Cancer Institute, Rome; Paolo Bidoli, Azienda Ospedaliera San Gerardo di Monza U.O. Oncologia Medica, Monza, Lombardia; Stefania Gori, Azienda Ospedaliera di Perugia, Ospedale S. Maria della Misericordia, Struttura Complessa di Oncologia Medica, Perugia, Umbria, and Azienda Ospedaliera Sacro Cuore-Don Calabria-Negrar, Negrar, Verona, Italy; Eva Ciruelos, Hospital Universitario 12 de Octubre, Madrid, Spain; Magdolna Dank, SE Radiológiai és Onkoterápiás Klinika; Lajos Hornyak, Veszprém Megyei Csolnoky Ferenc Kórház, Onkológiai Osztály, Budapest, Hungary; Sara Margolin, Karolinska University Hospital, Stockholm, Sweden; Arnd Nusch, Gem Praxis Drs Nusch, Kalhori und Langer, Friedrichstr, Velbert, Germany; and Michelle DeSilvio, Sergio Santillana, and Ramona F. Swaby, GlaxoSmithKline, Collegeville, PA. xavier.pivot@univ-fcomte.fr.
• J. Clin. Oncol. 2015 May 10; 33 (14): 1564-73.

PurposeCEREBEL compared the incidence of CNS metastases as first site of relapse in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer receiving lapatinib-capecitabine or trastuzumab-capecitabine.Patients And MethodsPatients without baseline CNS metastases were randomly assigned (1:1) to receive lapatinib-capecitabine (lapatinib 1,250 mg per day; capecitabine 2,000 mg/m(2) per day on days 1 to 14 every 21 days) or trastuzumab-capecitabine (trastuzumab loading dose of 8 mg/kg followed by an infusion of 6 mg/kg every 3 weeks; capecitabine 2,500 mg/m(2) per day on days 1 to 14 every 21 days). The primary end point was incidence of CNS metastases as first site of relapse. Secondary end points included progression-free survival (PFS) and overall survival (OS).ResultsThe study was terminated early with 540 enrolled patients (271 received lapatinib-capecitabine, and 269 received trastuzumab-capecitabine). Incidence of CNS metastases as first site of relapse was 3% (eight of 251 patients) for lapatinib-capecitabine and 5% (12 of 250 patients) for trastuzumab-capecitabine (treatment differences, -1.6%; 95% CI, -2% to 5%; P = .360). PFS and OS were longer with trastuzumab-capecitabine versus lapatinib-capecitabine (hazard ratio [HR] for PFS, 1.30; 95% CI, 1.04 to 1.64; HR for OS, 1.34; 95% CI, 0.95 to 1.64). Serious adverse events were reported in 13% (34 of 269 patients) and 17% (45 of 267 patients) of patients in the lapatinib-capecitabine and trastuzumab-capecitabine arms, respectively.ConclusionCEREBEL is inconclusive for the primary end point, and no difference was detected between lapatinb-capecitabine and trastuzumab-capecitabine for the incidence of CNS metastases. A better outcome was observed with trastuzumab-capecitabine in the overall population. However, lapatinib-capecitabine efficacy may have been affected by previous exposure to a trastuzumab regimen and/or when treatment was given as first- or second-line therapy in the metastatic setting.© 2015 by American Society of Clinical Oncology.

43 keywords...

hide…